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The main objective of this study is to monitor the safety and effectiveness of the OptEase™ Permanent Vena Cava (IVC) Filter
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPTEASE Vena Cava Filter | Device |
| Measure | Description | Time Frame |
|---|---|---|
| The co-primary endpoints are migration of the OptEase™ IVC filter as determined by abdominal x-ray at 1-month post-implantation and symptomatic thrombosis at 1-month post-implantation. Migration is defined as > 2 cm movement in either cranial or caudal |
| Measure | Description | Time Frame |
|---|---|---|
| To assess major adverse event rates related to the filter or filter procedure, up to 6-month follow-up, in aggregate and individually. Major adverse events are defined as 1) death, 2) pulmonary embolism, 3) symptomatic thrombosis, 4) caval penetration | ||
| To assess the longer-term stability of the filter defined by the lack of migration as seen on abdominal x-ray at 6-month post-implantation. Migration is defined as > 2 cm movement in either cranial or caudal direction as seen on abdominal x-ray compar |
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Inclusion Criteria:
· Pulmonary thromboembolism when anticoagulants are contraindicated.
Exclusion Criteria:
· Patients with risk of septic embolism.
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| Name | Affiliation | Role |
|---|---|---|
| Peter Weidenfeld, MD | Sunrise Hospital and Medical Center | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18656008 | Result | Ziegler JW, Dietrich GJ, Cohen SA, Sterling K, Duncan J, Samotowka M. PROOF trial: protection from pulmonary embolism with the OptEase filter. J Vasc Interv Radiol. 2008 Aug;19(8):1165-70. doi: 10.1016/j.jvir.2008.04.020. Epub 2008 Jun 27. |
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| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
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| To assess the clinical success of the filter up to 6-month follow-up. Clinical success is defined as the absence of symptomatic pulmonary embolism (PE) evaluated clinically at post-implantation, 1- and 6-months post-implantation. |
| To assess the technical success of the filter up to 6-month follow-up. Technical success is defined as the filter successfully deployed at the intended site in the IVC with the correct orientation. |
| To assess significant tilting (> 15° off the axis of the IVC) up to 6-month follow-up. |
| To assess filter fracture up to 6-month follow-up. |
| Procedure-related bleeding (defined as requiring transfusion or > 3 gm decrease in hemoglobin). |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |